FDA.reportPublic FDA data

VNS Therapy® AspireSR® Model 106 Generator

Primary DI
05425025750061
Brand
VNS Therapy® AspireSR® Model 106 Generator
Company
LIVANOVA USA, INC.
Model
106
Device description
Implantable Pulse Generator
Published
2015-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYJStimulator, Autonomic Nerve, Implanted For Epilepsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYJStimulator, Autonomic Nerve, Implanted For EpilepsyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970003173

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970003173VNS THERAPY SYSTEMLivaNova USA, Inc.1997-07-16LYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425025750061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425025750061054250257500615425025750061

GMDN Terms#

Term, Definition table
TermDefinition
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation systemAn assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (866) 882-8804ClinicalTechnicalServices@cyberonics.com

Regulatory Flags#

DUNS number
194568978
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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00803622163593Perfusion PackPerfusion Pack2026-05-27
00803622163616Perfusion PackPerfusion Pack2026-05-27
00803622163654Perfusion PackPerfusion Pack2026-05-27
00803622163678Perfusion PackPerfusion Pack2026-05-27
00803622163685Perfusion PackPerfusion Pack2026-05-27
00803622163746Perfusion PackPerfusion Pack2026-05-27
00803622163456Perfusion PackPerfusion Pack2026-05-18
00803622163463Perfusion PackPerfusion Pack2026-05-18
00803622163470Perfusion PackPerfusion Pack2026-05-18
00803622163500Perfusion PackPerfusion Pack2026-05-18
00803622163531Perfusion PackPerfusion Pack2026-05-18
00803622163555Perfusion PackPerfusion Pack2026-05-18
00803622163562Perfusion PackPerfusion Pack2026-05-18
00803622163579Perfusion PackPerfusion Pack2026-05-18
00803622163739Perfusion PackPerfusion Pack2026-05-18
00803622128370Tubing OrganizerAX-xxxxx2015-09-22
00803622161506Perfusion PackPerfusion Pack2026-05-08
00803622162145Perfusion PackPerfusion Pack2026-05-08
00803622163418Perfusion PackPerfusion Pack2026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05425025750634VNS Therapy™ Programmer, Model 3100 v1.1.0LIVANOVA USA, INC.LYJ2023-09-19
05425025750535VNS Therapy® Programmer, Model 3000 v1.6.2 LIVANOVA USA, INC.LYJ2021-03-01
05425025750528VNS Therapy® SenTiva Duo™ Model 1000-D GeneratorLIVANOVA USA, INC.LYJ2020-07-22
05425025750443VNS Therapy® Programmer, Model 3000 v1.6 LIVANOVA USA, INC.LYJ2019-09-09
05425025750429VNS Therapy® Programmer, Model 3000 v1.5 LIVANOVA USA, INC.LYJ2018-08-01
05425025750481VNS Therapy® Programmer, Model 3000 v1.0.2 LIVANOVA USA, INC.LYJ2018-02-16
05425025750177VNS Therapy® Programming Wand Model 2000LIVANOVA USA, INC.LYJ2017-10-06
05425025750399VNS Therapy® Programmer, Model 3000 v1.0 LIVANOVA USA, INC.LYJ2017-10-06
05425025750405VNS Therapy® SenTiva™ Model 1000 GeneratorLIVANOVA USA, INC.LYJ2017-10-06
05425025750375VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.LYJ2015-10-29
05425025750368VNS Therapy® Model 250 v11.0 Programming SoftwareLIVANOVA USA, INC.LYJ2015-06-02
05425025750382VNS Therapy® Model 250 v10.0 Programming SoftwareLIVANOVA USA, INC.LYJ2015-04-01
05425025750016VNS Therapy® Pulse Model 102 GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750023VNS Therapy® Pulse Duo Model 102R GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750030VNS Therapy® Demipulse® Model 103 GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750047VNS Therapy® Demipulse Duo® Model 104 GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750054VNS Therapy® AspireHC® Model 105 GeneratorLIVANOVA USA, INC.LYJ2014-09-17
05425025750092VNS Therapy® Model 302 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750108VNS Therapy® Model 302 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750115VNS Therapy® PerenniaDURA® Model 303 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750122VNS Therapy® PerenniaDURA® Model 303 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750139VNS Therapy® PerenniaFLEX® Model 304 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750153VNS Therapy® PerenniaFLEX® Model 304 LeadLIVANOVA USA, INC.LYJ2014-09-17
05425025750160NCP® Programming Wand Model 201LIVANOVA USA, INC.LYJ2014-09-17
05425025750184VNS Therapy® Model 250 v8.1 Programming Software (X50)LIVANOVA USA, INC.LYJ2014-09-17
05425025750191VNS Therapy® Model 250 v8.1 Programming Software (X5)LIVANOVA USA, INC.LYJ2014-09-17
05425025750214VNS Therapy® Model 250 v10.0 Programming SoftwareLIVANOVA USA, INC.LYJ2014-09-17
05425025750245VNS Therapy® Model 502 Accessory PackLIVANOVA USA, INC.LYJ2014-09-17